FDA rejects recommendation by advisory panel on use of Doribax

The Food and Drug Administration has declined to approve an expanded use of Doribax, a Johnson & Johnson antibiotic, despite an advisory panel’s favorable recommendation. That was the third time in a month for the FDA to refuse to follow the guidance of its outside experts. The FDA said it needed more information from J&J before it could approve Doribax to treat hospital-acquired pneumonia. The drug is currently approved for use in serious cases of abdominal and urinary-tract infections.

Although the FDA isn’t obligated to follow an advisory committee’s recommendations, it usually has done so in the past. In early August, however, a trend started when the FDA decided to reject Schering-Plough Corp.’s Sugammadex, a drug that helps patients recover from anesthesia, even though the panel decided unanimously to approve it. A week later, the agency said it needed three more months before it would decide whether to approve Ustekinumab, a J&J biologic drug for treating psoriasis, again despite another panel’s unanimous vote for approval. Now we see a third rejection with Doribax.

Hopefully, these decisions are a sign of the FDA’s increasing caution as well as its heightened attention to safety. The agency appears to be taking more time and asking for more data before it makes decisions. In the calendar year 2007, the FDA approved the fewest number of new drugs — 19 — in more than two decades, and ordered new or enhanced “black-box” warnings — the most serious type — for about 75 drugs, double the number from four years ago. In the case of Doribax, the advisory panel’s decision was mixed. Members voted 7-6 that the drug was efficacious and by 8-5 that it was safe. Several of the members questioned design aspects of the study used to test the drug. Interestingly, J&J said it was “reviewing the agency’s letter” and said it would work to “resolve any outstanding questions.” Regardless of what happens on Doribax, it’s extremely encouraging to see the FDA doing its job in a manner that makes safety of drugs a very high priority.